Foley Catheter Kit (Excludes Hiv Testing)

FDA product code PPB · Class II (moderate risk) · 21 CFR 876.5130 · Gastroenterology, Urology

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

0510(k) clearances
0PMA approvals
14recalls

Recalls

RecallProductFirmInitiated
Z-2024-2026 Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… Medline Industries, LP03/19/2026Open, Classified
Z-2117-2026 Class IIMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1396-2026 Class IIMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1599-2025 Class IIMedline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-1443-2025 Class IIMedline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield02/11/2025Open, Classified
Z-0785-2025 Class IIMedline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… MEDLINE INDUSTRIES, LP - Northfield11/21/2024Open, Classified
Z-0164-2025 Class IIMedline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… MEDLINE INDUSTRIES, LP - Northfield09/04/2024Open, Classified
Z-3112-2024 Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… MEDLINE INDUSTRIES, LP - Northfield06/27/2024Open, Classified
Z-3012-2024 Class IIMedline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2706-2024 Class IIMedline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410AA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. MEDLINE INDUSTRIES, LP - Northfield03/22/2024Open, Classified
Z-1106-2024 Class IMEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… MEDLINE INDUSTRIES, LP - Northfield11/15/2023Open, Classified
Z-2176-2023 Class IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. MEDLINE INDUSTRIES, LP - Northfield05/18/2023Open, Classified
Z-2316-2023 Class IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. MEDLINE INDUSTRIES, LP - Northfield05/15/2023Open, Classified
Z-1076-2023 Class IISterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDOSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified